510(k) K955436 ยท CDD Radioassay, Vitamin B12
ACCESS VITAMIN B12 ASSAY (MODIFICATION)
| Applicant | Bio-Rad Laboratories, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Jan 24, 1996 |
| Received | Oct 2, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K955436
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 11, 2025 | Beckman Coulter, Inc. Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850 Completed |
CDD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.